YHLO received its first IVDR, paving the way for EU IVD market
In this October, YHLO proudly announced that it has received its first IVDR Certificate from BSI, one of the most reputable notified bodies under the In Vitro Diagnostics Regulation (IVDR). The certificate covers Anti-TPO—a Thyroid Peroxidase Antibody Assay Test Kit, PCT—A Procalcitonin Assay Test Kit and etc., which are applied to Chemiluminescence Immunoassay platform.
Manufacturers of in-vitro diagnostic instruments and regents are required to obtain certifications and display CE mark in principle after 26 May 2022 in order to enter the EU market. These certifications confirm that the products meet the IVDR’s high quality standards, which focus on protecting the health of patients and users. Compared to IVDD, IVDR has a risk classification of IVD devices, tightened requirements for post-market surveillance and vigilance, and tightened requirements for clinical evidence and conformity assessment.
In order to supply reliable products and services to customers, YHLO team has been working hard to obtain the CE mark in accordance with the IVDR. With the mission of “Focus on healthcare, better life with technology”, YHLO will continue to provide reliable, high-quality healthcare innovations and services worldwide to improve human well-being.
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n November 18, 2025, YHLO’s 2025 Global Core Distributors Conference was successfully held in Düsseldorf, Germany. Under the theme “Academia-Driven, Shared Value,” the meeting brought together representatives from more than 30 core distributors worldwide. YHLO’s founder, Mr. Deming Hu, and Chairman, Mr. Kunhui Hu, led the company’s executive team to attend and discuss strategic development with partners.
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YHLO Secures Approval for the World’s First sCD146 CLIA Assay
YHLO has obtained approval from the Guangdong Medical Products Administration for its soluble CD146 (sCD146) CLIA assay, marking a major milestone in central nervous system (CNS) disease diagnostics. YHLO is now the first company worldwide to offer an sCD146 test for cerebrospinal fluid, bringing its total CLIA assay portfolio in China to 173.
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Add: Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, 518116 Shenzhen, P.R.China
